Trial Outcomes & Findings for Tositumomab and Iodine I 131 Tositumomab in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma in First Remission (NCT NCT00476047)

Last Updated: 2017-10-12

Results Overview

Progression free survival (PFS) is defined as the interval between the first treatment day to the first sign of disease progression. This outcome measures the percentage of participants with PFS at 36 months.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

36 months

Results posted on

2017-10-12

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Monoclonal Antibody Therapy) Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes. Tositumomab and Iodine I 131 Tositumomab: Give IV Laboratory Biomarker Analysis: Correlative studies
Overall Study STARTED	16
Overall Study Completed Treatment	16
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Monoclonal Antibody Therapy) Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes. Tositumomab and Iodine I 131 Tositumomab: Give IV Laboratory Biomarker Analysis: Correlative studies
Overall Study Lost to Follow-up	1

Baseline Characteristics

Tositumomab and Iodine I 131 Tositumomab in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma in First Remission

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Monoclonal Antibody Therapy) n=16 Participants Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes. Tositumomab and Iodine I 131 Tositumomab: Give IV Laboratory Biomarker Analysis: Correlative studies
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
CLL or SLL CLL (Chronic lymphocytic leukemia)	11 Participants n=5 Participants
CLL or SLL SLL (Small lymphocytic leukemia)	5 Participants n=5 Participants
Prior chemotherapy FR (fludaribine and rituximab)	9 Participants n=5 Participants
Prior chemotherapy FCR(fludaribine, cyclophosphamide and rituximab)	4 Participants n=5 Participants
Prior chemotherapy BR (bendamustine and rituximab)	2 Participants n=5 Participants
Prior chemotherapy R-CHOP	1 Participants n=5 Participants
Disease status before 131 I-tositumomab CR (complete response)	4 Participants n=5 Participants
Disease status before 131 I-tositumomab PR (partial response)	12 Participants n=5 Participants
Minimal Residual Disease (MRD) status before 131 I-tositumomab Positive	12 Participants n=5 Participants
Minimal Residual Disease (MRD) status before 131 I-tositumomab Negative	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 36 months

Outcome measures

Outcome measures
Measure	Treatment (Monoclonal Antibody Therapy) n=16 Participants Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes. Tositumomab and Iodine I 131 Tositumomab: Give IV Laboratory Biomarker Analysis: Correlative studies
Probability of Progression-free Survival (PFS)	52 percentage probability Interval 25.0 to 74.0

PRIMARY outcome

Timeframe: 3 months after 131I-tositumomab consolidation

Population: Participants who had a partial response (PR) after initial chemotherapy. Response assessed using NCI working group guidelines + CT criteria as described in the protocol.

Response rates determined using National Cancer Institute (NCI) working group guidelines plus computed tomography (CT) scan criteria. Participants were assessed for response after initial chemotherapy and again 3 months after 131I-tositumomab treatment.Only patients who had less than a complete response (CR) after initial chemotherapy were assessed for improved response after 131I-tositumomab.

Outcome measures

Outcome measures
Measure	Treatment (Monoclonal Antibody Therapy) n=12 Participants Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes. Tositumomab and Iodine I 131 Tositumomab: Give IV Laboratory Biomarker Analysis: Correlative studies
Improved Response Rate After Treatment With 131I-tositumomab for Patients Who Had Evidence of CLL at the End of Initial Chemotherapy Participants who achieved a CR	8 Participants
Improved Response Rate After Treatment With 131I-tositumomab for Patients Who Had Evidence of CLL at the End of Initial Chemotherapy Participants who did not achieve a CR	4 Participants

PRIMARY outcome

Timeframe: 3 months after 131I-tositumomab consolidation

Outcome measures

Outcome measures
Measure	Treatment (Monoclonal Antibody Therapy) n=4 Participants Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes. Tositumomab and Iodine I 131 Tositumomab: Give IV Laboratory Biomarker Analysis: Correlative studies
Minimal Residual Disease (MRD) by Flow Cytometry or Polymerase Chain Reaction (PCR) in Patients Who Had a Complete Remission (CR) After Any Prior Therapy Negative MRD status	4 Participants
Minimal Residual Disease (MRD) by Flow Cytometry or Polymerase Chain Reaction (PCR) in Patients Who Had a Complete Remission (CR) After Any Prior Therapy Positive MRD status	0 Participants

SECONDARY outcome

Timeframe: 48 months (median)

Adverse events following treatment of 131I-tositumomab

Outcome measures

Outcome measures
Measure	Treatment (Monoclonal Antibody Therapy) n=16 Participants Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes. Tositumomab and Iodine I 131 Tositumomab: Give IV Laboratory Biomarker Analysis: Correlative studies
Evaluate Toxicities of 131I-tositumomab Grade 3 anemia	1 participants with this toxicity
Evaluate Toxicities of 131I-tositumomab Grade 3 or 4 neutropenia	13 participants with this toxicity
Evaluate Toxicities of 131I-tositumomab Grade 3 or 4 thrombocytopenia	8 participants with this toxicity
Evaluate Toxicities of 131I-tositumomab Hypogammaglobulinemia	1 participants with this toxicity
Evaluate Toxicities of 131I-tositumomab Neutropenia related sepsis/typhlitis	1 participants with this toxicity
Evaluate Toxicities of 131I-tositumomab Basal cell carcinoma	2 participants with this toxicity
Evaluate Toxicities of 131I-tositumomab Squamous cell carcinoma	1 participants with this toxicity
Evaluate Toxicities of 131I-tositumomab Myelodysplastic syndrome	2 participants with this toxicity

Adverse Events

Treatment (Monoclonal Antibody Therapy)

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Monoclonal Antibody Therapy) n=16 participants at risk Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes. Tositumomab and Iodine I 131 Tositumomab: Give IV Laboratory Biomarker Analysis: Correlative studies
Blood and lymphatic system disorders Anemia Grade 3	6.2% 1/16 • Number of events 1
Blood and lymphatic system disorders Neutropenia Grade 3 or 4	81.2% 13/16 • Number of events 16
Blood and lymphatic system disorders Thrombocytopenia Grade 3 or 4	50.0% 8/16 • Number of events 16

Additional Information

Mazyar Shadman, MD

Fred Hutchinson Cancer Research Ctr

Phone: 2066675467

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place